UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026179 |
|---|---|
| Receipt number | R000030081 |
| Scientific Title | The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama". :A randomization open-label, non-eating simultaneous control comparison group study. |
| Date of disclosure of the study information | 2017/02/17 |
| Last modified on | 2018/01/09 23:09:37 |
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Basic information
Public title
The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
:A randomization open-label, non-eating simultaneous control comparison group study.
Acronym
The clinical trial for anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
Scientific Title
The investigation of anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
:A randomization open-label, non-eating simultaneous control comparison group study.
Scientific Title:Acronym
The clinical trial for anti-fatigue effect associated with ingestion of Ripe Kumquats "Tama-Tama".
Region
| Japan |
Condition
Condition
Healthy adults.
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical benefits, such as anti-fatigue effect, associated with four weeks daily ingestion of ripe kumquats "Tama-Tama" for the healthy adult.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Total score of Chalder fatigue scale at first day, four weeks and eight weeks after ingestion of ripe kumquats.
Key secondary outcomes
1. VAS score
2. QOL scales (SF-36)
3. Symptom scores of upper respiratory tract infections(URTI)
4. Duration of illness, the number of days from the onset to the complete disappearance of URTI symptoms
5. Percentage of visiting physicians due to symptoms of URTI
6. Incidence rate of influenza
7. Restriction of daily activities
8. Adverse events
(VAS score and QOL scales are assessed on the first day, four weeks and eight weeks after ingestion of ripe kumquats "Tama-Tama".)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The subjects take Kumquat "Tama-Tama" five pieces per day for four weeks
Interventions/Control_2
The subjects don't take Kumquat "Tama-Tama" for four weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who are 35-55 years old at informed consent.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Subjects who don't fill any item of self-reported health questionnaire.
2. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases on self-reported health questionnaire.
3. Subjects who have a serious injury or surgical history within 12 weeks prior to this study.
4. Pre- or post-menopausal women having obvious changes in physical condition.
5. Subjects who are at risk of having allergic reaction to citrus foods including kumquat.
6. Subjects who have history of allergic reaction to foods or drugs which needs its treatment or who have possibility of the reaction.
7. Subjects who are heavy smoker (more than 21 cigarettes per day), alcohol dependency or drug dependency or who have possibility of these dependency.
8. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
9. Pregnant or lactating women or women expect to be pregnant during this study.
10. Subjects who have cognitive disorder or who have possibility of the disorder.
11. Subjects who participate and take the study drug in other clinical trials before this study.
12. Subjects who are judged as unsuitable for this study by the principal investigator or subinvestigators.
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuji Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, University of Miyazaki hospital
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9577
yasuji_arimura@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuji Arimura |
Organization
University of Miyazaki
Division name
Clinical research support center, University of Miyazaki hospital
Zip code
Address
Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
TEL
0985-85-9577
Homepage URL
yasuji_arimura@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Miyazaki Brand Promotion Headquarters
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 06 | Month | 13 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030081
